A Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00708201
First received: June 27, 2008
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:

  • to evaluate the effect of alvimopan on hospital length of stay;
  • to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities
  • to evaluate the overall and cardiovascular safety of alvimopan

Condition Intervention Phase
Postoperative Ileus
Drug: alvimopan
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food. This endpoint is referred to as GI2. [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to ready for discharge [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
  • Time to discharge order written [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • incidence of adverse events [ Time Frame: up to 30 days or until resolution ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 280
Study Start Date: March 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Alvimopan 12 mg
Drug: alvimopan
Alvimopan, 12mg, capsule. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment
Other Names:
  • ADL2698
  • Entereg
Placebo Comparator: B
300 mg polyethylene glycol in a No. 1 Swedish Orange gelatin capsule
Drug: Placebo
300 mg polyethylene glycol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • are either Male or Female at least 18 years of age
  • are scheduled for radical cystectomy
  • are scheduled to receive postoperative pain management with intravenous patient-controlled opioid analgesics

Exclusion Criteria:

  • are scheduled for a partial cystectomy
  • have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708201

Locations
United States, California
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago, Section of Urology MC6038
Chicago, Illinois, United States, 60637
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota Hospital
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
CRC of Jackson
Jackson, Mississippi, United States, 39202
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Oregon Health and Science University Knight Cancer Institute
Portland, Oregon, United States, 97239
United States, Tennessee
Vanderbilt University Medical Center, Department of Urology Surgery
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Lee Techner, DPM Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00708201     History of Changes
Other Study ID Numbers: 14CL403
Study First Received: June 27, 2008
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
ileus
POI

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Alvimopan
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014